Federal Food, Drug, and Cosmetic Act in the context of "Medical instrumentation"

A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.

Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States, it was not until the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 1938 that medical devices were regulated at all. It was not until later in 1976 that the Medical Device Amendments to the FD&C Act established medical device regulation and oversight as we know it today in the United States. Medical device regulation in Europe as we know it today came into effect in 1993 by what is collectively known as the Medical Device Directive (MDD). On May 26, 2017, the Medical Device Regulation (MDR) replaced the MDD.

The Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed, and veterinary products.

The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs but involves other factors like regulating lasers, cellular phones, and condoms. In addition, the FDA takes control of diseases in the contexts varying from household pets to human sperm donated for use in assisted reproduction.

Infant formula, also called baby formula, simply formula (American English), formula milk, baby milk, or infant milk (British English), is a manufactured food designed and marketed for feeding babies and infants under 12 months of age, usually prepared for bottle-feeding or cup-feeding from powder (mixed with water) or liquid (with or without additional water). The U.S. Federal Food, Drug, and Cosmetic Act (FFDCA) defines infant formula as "a food which purports to be or is represented for special dietary use solely as a food for infants because it simulates human milk or its suitability as a complete or partial substitute for human milk".

A 2001 World Health Organization (WHO) report found that infant formula prepared per applicable Codex Alimentarius standards was a safe complementary food and a suitable breast milk substitute. In 2003, the WHO and UNICEF published their Global Strategy for Infant and Young Child Feeding, which restated that "processed-food products for ... young children should, when sold or otherwise distributed, meet applicable standards recommended by the Codex Alimentarius Commission", and also warned that "lack of breastfeeding—and especially lack of exclusive breastfeeding during the first half-year of life—are important risk factors for infant and childhood morbidity and mortality".

Generally recognized as safe (GRAS) is a United States Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts under the conditions of its intended use. An ingredient with a GRAS designation is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements.

Some examples of substances recognized as GRAS include ascorbic acid (vitamin C), citric acid, and salt, which are all commonly used in food preservation and flavoring. The concept of food additives being "generally recognized as safe" was first described in the Food Additives Amendment of 1958, and all additives introduced after this time had to be evaluated by new standards.

Charles W. Crawford (July 21, 1888 – September 15, 1957) was an American chemist who served as Commissioner of Food and Drugs from 1951 to 1954. He graduated Oklahoma A&M University with a BA degree in chemistry in 1909. He later received a master's degree in 1915. He quickly became the FDA's principal representative during the drafting of the 1938 Food, Drug, and Cosmetic Act.